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3. Schedule 1 to the principal Regulations shall be amended as follows:—
(a)in Part I (permitted sweeteners) after the item relating to“Isomalt” there shall be inserted—
| In column 1 | In column 2 |
|---|---|
| (Name of Sweetener) | (Serial Number) |
| “Lactitol ... ... ... ...| | ” ; |
(b)in Part II (specific purity criteria for permitted sweeteners) after the item relating to“Isomalt” there shall be inserted—
| “Lactitol | |
| Synonyms ... ... ... ... | Lactit, Lactositol, Lactobiosit. |
| Chemical name ... ... ... ... | 4-0-(β:-D-galactopyranosyl)-D-glucitol. |
| Empirical formula ... ... ... ... | C12H24O11. |
| Molecular weight ... ... ... ... | 344.32. |
| Specific rotation, [α] 20°C D | + 13° to + 15° (using a 10% weight to volume aqueous solution). |
| Water ... ... ... ... | Lactitol monohydrate not more than 5.5% (Karl Fischer). Lactitol dihydrate not more than 10.5% (Karl Fischer). |
| Description ... ... ... ... | Colourless, aqueous syrup with a sweet taste. When dried, the resulting products, lactitol monohydrate and lactitol dihydrate, are white, odourless and crystalline. |
| Content ... ... ... ... | Not less than 97.5% 4-0-(β-D- galactopyranosyl)-D-glucitol on a dry weight basis. |
| Other polyols ... ... ... ... | Not more than 2.5% on a dry weight basis. |
| Reducing sugars ... ... ... ... | Not more than 0.2% on a dry weight basis, expressed as lactose. |
| Chlorides ... ... ... ... | Not more than 100 mg/kg on a dry weight basis, expressed as Cl. |
| Sulphate ... ... ... ... | Not more than 100 mg/kg on a dry weight basis, expressed as SO4. |
| Arsenic ... ... ... ... | Not more than 1 mg/kg on a dry weight basis, expressed as As. |
| Nickel ... ... ... ... | Not more than 1 mg/kg on a dry weight basis, expressed as Ni. |
| Lead ... ... ... ... | Not more than 1 mg/kg on a dry weight basis, expressed as Pb. |
| Ash ... ... ... ... | Not more than 0.1% after ignition at 800 ± 25°C calculated on a dry weight basis.”. |
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